Leptospirosis Registry - LeptoScope

NCT04288674 | Recruiting

• 1 other identifier: Version 1.0
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Leptospirosis is a worldwide zoonotic diseases caused by pathogenic Leptospira spp. Human are accidental hosts, who acquired infections after exposition to animal urine, contaminated water or soil, infected tissue. Incidence of invasive leptospirosis disease causing acute kidney injury, acute respiratory distress syndrome (ARDS), myocarditis, hepatic dysfunction, hemorrhage and multi-organ failure, is globally increasing and there have been frequent outbreak situation throughout the world. Due to increasing outbreak situations and globally chances in species distributions, a worldwide surveillance in epidemiology and species distribution is urgently needed. The objective of the Leptospirosis Registry - LeptoScope is to overcome the lack knowledge on epidemiology, clinical course, prognostic factors and molecular characteristics for invasive leptospirosis disease.

Conditions

Leptospirosis

Outcome Measures

Primary Outcomes (2)

• Incidence

  To describe the global incidence of invasive leptospirosis disease

  up to 100 weeks

• Mortality

  To describe global mortality due to invasive leptospirosis disease

  up to 100 weeks

Secondary Outcomes (8)

• Resistance development

  up to 100 weeks

• Treatment efficacy of invasive leptospirosis disease in participants with treatment failure

  at 90 days from diagnosis

• Treatment efficacy of invasive leptospirosis disease in participants with stable disease

  at 90 days from diagnosis

• Treatment efficacy of invasive leptospirosis disease in participants with partial responses

  at 90 days from diagnosis

• Treatment efficacy of invasive leptospirosis disease in participants with complete responses

  at 90 days from diagnosis

Study Arms (2)

Leptospirosis group

Patients with cultural, serological, molecular or histological evidence and clinical evidence of invasive leptospirosis disease.

Other: Retrospective data collection of demographics; Other: Retrospective data collection of underlying diseases; Other: Retrospective data collection of duration of hospitalization

Control group

Controls will be included at the same hospitals that conduced cases based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital)

Other: Retrospective data collection of demographics; Other: Retrospective data collection of underlying diseases; Other: Retrospective data collection of duration of hospitalization

Interventions

Retrospective data collection of underlying diseases OTHER

Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.

Control group; Leptospirosis group

Retrospective data collection of duration of hospitalization OTHER

Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.

Control group; Leptospirosis group

Retrospective data collection of demographics OTHER

Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.

Control group; Leptospirosis group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective data collection from patients with cultural, serological, molecular or histological evidence of Leptospirosis spp. infection and clinical evidence of invasive leptospirosis disease (acute kidney injury, pulmonary manifestation with acute respiratory distress syndrome (ARDS), myocarditis with arrhythmia, hepatic dysfunction, hemorrhage, multi-organ failure). Particularly, controls will be included at the same hospitals that conduced cases based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital).

You may qualify if:

• Cultural, serological, molecular or histological evidence of invasive leptospirosis diseases
• Clinical signs of disseminated leptospirosis disease without cultural, serological, molecular or histological evidence
• Case controls: Matching procedures for controls: Particularly, case controls will be included at the same hospitals that conduced cases based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital).

You may not qualify if:

• Colonization or other non-invasive infection
• Cultural, serological, molecular or histological evidence without dissemination

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Related Links

• Related information

MeSH Terms

Conditions

Leptospirosis

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Volker Burst, MD

  University Hospital of Cologne

  STUDY CHAIR

• Felix Köhler, MD

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Köhler, MD

CONTACT

+4922147897222; felix.koehler@uk-koeln.de

Felix Köhler, MD

CONTACT

kidneyinfection@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 28, 2020
• Study Start: March 4, 2020
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)